Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy

Tongji Hospital

Status: Completed

Conditions: Endoscopy, Gastrointestinal

Treatments: Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06419543

PRPG

Details and patient eligibility

About

Exploring the effect of remimazolam dose on paradoxical reactions in pediatric painless gastrointestinal endoscopy.

Full description

Exploring the effect of remimazolam dose on paradoxical reactions and sedation in pediatric painless gastrointestinal endoscopy, observing the performance and duration of paradoxical reactions, and analyze the factors.

Enrollment: 333 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 1-12 years old
• ASA I-II level
• Sign an informed consent form

Exclusion criteria

• Developmental delay or neurological and psychiatric disorders
• Severe malnutrition or severe obesity
• High risk of stomach fullness and reflux aspiration
• Allergic to benzodiazepines and opioids
• Those who have taken sedative, analgesic, or antidepressant drugs within 24hours
• Severe sleep apnea
• Abnormal liver and kidney function
• Recently participated in other clinical studies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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333 participants in 3 patient groups

Group R1

Experimental group

Description:

The first induction dose of remimazolam is 0.1mg/kg.

Treatment:

Drug: Remimazolam

Group R2

Experimental group

Description:

The first induction dose of remimazolam is 0.2mg/kg.

Treatment:

Drug: Remimazolam

Group R3

Experimental group

Description:

The first induction dose of remimazolam is 0.3mg/kg.

Treatment:

Drug: Remimazolam